Implantable medical device including a molded planar transformer

ABSTRACT

The present disclosure provides methods and techniques associated with a planar transformer for an apparatus. The planar transformers include a substrate carrying electronic components and a continuous core that is formed by distributing the encapsulant material uniformly around the substrate unit to define a consistent cross-sectional area for the magnetic path. The electronic components include primary windings and secondary windings associated with the transformer. In some embodiments, the encapsulant material is molded to seals air gaps to the substrate unit.

FIELD

The present disclosure generally relates to an implantable medicaldevice, and more particularly to transformer assemblies incorporatedinto the medical device and associated methods for making thetransformer assemblies.

BACKGROUND

An implantable medical device (IMD) such as an implantable cardioverterdefibrillator (ICD) may be used to deliver shock therapy to a patient'sheart in order to perform therapies such as defibrillation andcardioversion. Some ICDs may also provide several different pacingtherapies, including such therapies as cardiac resynchronization,depending upon the needs of the user or patient and the medicalcondition of the patient's heart. For convenience, all types ofimplantable medical devices will be referred to herein as IMDs, it beingunderstood that the term, unless otherwise indicated, is inclusive of animplantable device capable of administering a cardiac therapy.

In IMDs that deliver defibrillation or cardioversion therapies, it isnecessary to develop high voltages, perhaps 750 volts or more, withinthe IMD in order to administer a sufficient shock to a patient tocorrect an arrhythmia or a fibrillation, particularly a ventricularfibrillation. To generate such high voltages, a battery and capacitors(usually two) may be used. Preferably, the capacitors are fully chargedbefore defibrillation or cardioversion therapies are delivered. In someconfigurations, flyback and non-flyback transformers are employed toincrementally charge the defibrillation capacitors prior to therapydelivery. Once the capacitors are charged, the defibrillation orcardioversion therapy is delivered via insulated gate bipolartransistors or other suitable semiconductor switches that are switchedon and off to apply charge stored in the capacitors in biphasic pulsewaveform to the heart.

Because IMDs are implanted subcutaneously, it is preferable that the IMDis sized as small as possible to reduce any discomfort that the patientmay experience post-implantation. Conventionally, however, some of theelectronic components that are housed within the IMD are relativelylarge. For example, transformers are used which have coil and coremembers that are physically separate from other IMD components. Althoughthese conventional transformers have been reliable, they occupy aconsiderable amount of space within the IMD.

Accordingly, it remains desirable to provide a method and apparatus fordecreasing the size of a transformer for use in an implantable medicaldevice, while maintaining its reliability.

SUMMARY

The present disclosure is directed to an IMD having a hermeticallysealed chamber defined by a hermetically sealed housing. Containedwithin the housing is a power source, a capacitor bank for storing acharge from the power source, and electronic circuitry coupled to thepower source and the capacitor bank for charging the capacitor bankthrough a transformer and for discharging the capacitor-bank charge intoselected body tissue.

In an embodiment, techniques are described for making transformerassemblies that are miniaturized sufficiently to fit within small spacesof the housing cavity. The transformer assemblies are provided having asubstrate unit that is sandwiched between a pair of cores including anupper and a lower core, both of which may be comprised of a magneticmaterial. In one embodiment, a transformer assembly includes a substrateunit having electronic components arranged therein. The electroniccomponents arranged in the substrate unit may include primary andsecondary windings. A first of the pair of cores, for example, the uppercore, is disposed on a top surface of the substrate unit. A second ofthe pair of cores, for example the lower core, is disposed on a bottomsurface of the substrate unit. The transformer further includes anencapsulant material that is dispensed over the upper core and withinthe gaps between the upper core and the electronic components of thesubstrate unit. The encapsulant material functions to couple andpermanently position the upper core to the top surface. Similarly, thelower core may be permanently positioned on the bottom surface withencapsulant material, while in other embodiments, an adhesive materialmay be applied to affix the lower core to the substrate unit. In anembodiment, the encapsulant material is formed to expose a surface ofthe upper and/or lower cores, such surface being parallel to the topsurface of the substrate unit.

In a second embodiment, a transformer assembly includes a substrate unithaving electronic components and including primary and secondarywindings embedded within the substrate unit. The substrate unit may befully (or substantially) encapsulated by a core that includes an uppercore and a lower core. The upper and lower cores may be assembled toeliminate an air gap therebetween. For example, the upper and lowercores may be formed in a molding process from a liquefied encapsulantmaterial that is dispensed to encapsulate the substrate unit.

According to an embodiment of the disclosure, a method for forming atransformer assembly is disclosed. In accordance with the method, asubstrate having a plurality of substrate units is provided with each ofthe substrate units including electronic components. In an embodiment,the electronic components include primary and secondary windingsassociated with a transformer. The substrate is mounted to a firstsurface of an adhesive material and a carrier plate is mounted to asecond surface of the adhesive material. An upper core is placed overeach of the substrate units. An encapsulation of the assembly includingthe substrate and the upper core is performed by molding to continuouslyencapsulate the portion of the assembly adhered to the first surface ofthe adhesive material. In an embodiment, molding includes dispensing anencapsulant material between the air gaps formed by the electroniccomponent and the upper core of each of the substrate units. Thesubstrate is subsequently detached from the adhesive material and alower core is bonded to each of the substrate units. In an embodiment,the plurality of substrate units are separated into individual units.

In another embodiment, a method for manufacturing a transformer assemblyincludes encapsulating a substrate unit with an encapsulant material.The substrate unit includes electronics and primary and secondarywindings for the transformer. The encapsulant material is formed as aunitary/continuous member to define a homogeneous core of thetransformer, with the windings and/or electronics being embedded withinthe core. In one embodiment, the core may be formed by distributing theencapsulant material uniformly around the windings to define aconsistent cross-sectional area. The encapsulant material may include apolymer bonded magnetic compound.

BRIEF DESCRIPTION

The following drawings are illustrative of particular embodiments of thepresent invention and therefore do not limit the scope of the invention.The drawings are not to scale (unless so stated) and are intended foruse in conjunction with the explanations in the following detaileddescription. Embodiments will hereinafter be described in conjunctionwith the appended drawings wherein like numerals/letters denote likeelements, and:

FIG. 1 illustrates an implantable system in accordance with oneexemplary embodiment;

FIG. 2 depicts a simplified block diagram of exemplary circuitry 30 thatmay be housed within the IMD 20;

FIG. 3A illustrates a cross-sectional view of a transformer assembly inaccordance with an embodiment;

FIG. 3B illustrates a cross-sectional view of an alternative transformerassembly;

FIG. 4 illustrates a cross-sectional view of another alternativetransformer assembly;

FIGS. 5A to 5E depict cross-sectional views of a transformer assemblysuch as that shown in any one of FIGS. 3A and 3B associated with amethod for fabrication of the transformers;

FIGS. 6A-6C depict cross-sectional views of a transformer assembly suchas that shown in any one of FIGS. 3A and 3B associated with analternative method for fabrication of the transformers; and

FIGS. 7A and 7B depict cross-sectional views of a transformer assemblysuch as that shown in any one of FIG. 4 associated with an alternativemethod for fabrication of the transformers.

DETAILED DESCRIPTION

The following detailed description is illustrative in nature and is notintended to limit the embodiments of the invention or the applicationand uses of such embodiments. Furthermore, there is no intention to bebound by any expressed or implied theory presented in the precedingtechnical field, background, brief summary or the following detaileddescription.

In the present disclosure, the inventors have disclosed deviceassemblies and methods for construction associated with transformers.The transformer is one of the constituent electrical components of animplantable medical device and is utilized to convert low batteryvoltage into a high voltage that is sufficient to charge capacitors thatare used to deliver an electrical stimulating therapy. Conventionaltransformers are built by winding a wire onto a toroid magnetic core.Due to the relatively small size, some of the winding process is manual,which results in significant cost and performance variability. Theinventors have observed that the conventional transformer is generallythe largest and tallest component in relation to other electricalcomponents of the implantable medical device. The inventors have alsoobserved that the rigidity and fragility of conventional discrete corescreates challenges in reducing the dimensions of the transformer. Inaccordance with embodiments of the present disclosure, processingtechniques and/or materials are described that provide the ability toachieve transformer packages with desired dimensions that may be smallerthan those that are achievable with the conventional discrete cores.

FIG. 1 illustrates an implantable system in accordance with oneexemplary embodiment of the disclosure. An implantable medical device(IMD) 20 is implanted in a body 10 near a heart 12. IMD 20 includescircuitry, a battery and other components that are contained within ahermetically sealed, biologically inert outer canister or housing thatmay be conductive so as to serve as a pace/sense electrode in thepacing/sensing circuit. One or more leads, collectively identified withreference numeral 22, electrically couple to the IMD 20 and extend intothe heart 12. In the case where device 20 is a pacemaker, leads 22 arepacing and sensing leads to sense electrical signals attendant to thedepolarization and repolarization of the heart 12 and provide pacingpulses in the vicinity of the distal ends thereof. One or more exposedconductive pace/sense electrode(s) for sensing electrical cardiacsignals or delivering electrical pacing pulses to the heart 12 aredisposed at or near the distal ends of the leads 22. The leads 22 may beimplanted with their distal ends situated in the atrium and/orventricles of the heart 12 or elsewhere in cardiac blood vessels inoperative relation with a heart chamber. The leads 22 can also carryother sensors for sensing cardiac physiologic data, e.g. pressure,temperature, impedance, pH, blood gas, acceleration, etc.

IMD 20 may also be a pacemaker/cardioverter/defibrillator (PCD)corresponding to any of the various commercially-available implantablePCDs. Those and other alternative implantable devices may be employedusing the present disclosure in that such devices may employ or bemodified with circuitry and/or systems according to the presentdisclosure. Examples of such alternative devices of IMD 20 may be animplantable nerve stimulator or muscle stimulator. In fact, the presentdisclosure is believed to find wide application in any form of anelectrical device, and is further believed to be particularlyadvantageous where low power consumption is desired, particularly inbattery powered devices.

In general, IMD 20 includes a hermetically-sealed enclosure thatincludes a power source and circuitry to control therapy delivery toheart 12. The circuitry may be implemented in discrete logic and/or mayinclude a microcomputer-based system with A/D conversion.

FIG. 2 provides a simplified block diagram of exemplary circuitry 30that may be housed within the IMD 20 and is configured to produce pulsesthat are used to pace the heart; i.e., cause a depolarization of theheart tissue or issue a defibrillation pulse to shock the heart fromarrhythmia to a normal heart beat. Circuitry 30 is shown to include apower source 32 electrically coupled to a controller 34 and a shockingcircuit 36. Although circuitry 30 depicts three components, it will beappreciated that fewer or more components may be employed. Power source32 is configured to provide operating power to controller 34 andshocking circuit 36 and is preferably capable of operating at lowcurrent drains over a long duration and at high current pulses whenshock delivery to patient 10 is required. Any one of numerous types ofappropriate batteries may be used, such as, for example lithium/silvervanadium oxide batteries.

Controller 34 controls the delivery of energy through lead 22 (shown inFIG. 1). Controller 34 is preferably configured to determine when,where, and for what duration the energy may be delivered. In thisregard, any one of numerous types of suitable control circuitry, such asmicroprocessors; or circuitry including memory, logic and timingcircuitry; and I/O circuitry, may be employed.

Shocking circuit 36 is configured to generate low or high energyshocking pulses and to deliver the shocking pulses to patient 10 inresponse to control signals from controller 34. In this regard, shockingcircuit 36 includes a transformer assembly 38 that is coupled to atleast one capacitor 40, which is in turn coupled to a delivery switch42. Transformer assembly 38 is configured to operate according to theprinciples of a flyback inductor, and thus, receives voltage from powersource 32 to be converted to an appropriate voltage to be used byshocking circuit 36. The converted voltage is stored in capacitor 40, orany other suitable energy storage device, until the shocking pulse isready to be delivered. When ready, delivery switch 42 is switched froman off position to an on position thereby routing the shocking pulse tothe appropriate leads.

Referring now to FIG. 3A, a cross-sectional view of a transformerassembly 38 a in accordance with an embodiment of the disclosure isdisclosed. The transformer assembly 38 a is shown having a substrateunit 50 and an upper magnetic core 56 disposed over an exterior surfaceof the substrate unit 50. By way of illustration, the portion of theexterior surface to which the upper magnetic core 56 will be referred toas a top surface. An encapsulant material 54 is dispensed over exteriorsurfaces of the upper magnetic core 56 and the substrate unit 50 forencapsulation of both the upper magnetic core 56 and substrate unit 50.In an embodiment, the encapsulant material is further dispensed betweenone or more gaps formed between the substrate unit 50 and the uppermagnetic core 56 to eliminate the air gaps therebetween and form an airtight seal. The encapsulant material 54 is formed to expose a surface ofthe upper magnetic core 56 that is parallel to the top surface of thesubstrate unit 50. The transformer assembly 38 a further includes alower magnetic core 58 that is bonded to an exterior surface of thesubstrate unit 50. For ease of discussion, the portion of the exteriorsurface to which the lower magnetic core 58 is bonded will be referredto as a bottom surface.

The substrate unit 50 includes one or more electronic components 52 thatmay be partially or fully embedded into the substrate unit 50. Theelectronic components 52 may include a set of primary windings andsecondary windings. In one configuration, the primary windings aredisposed in an overlapping relation to the secondary windings. Inanother embodiment, the primary windings may be configured in anon-overlapping relation to the secondary windings. A pair of terminalconnectors 60 is provided for coupling to the primary windings and thesecondary windings, respectively. The terminal connectors 60 may beformed at least partially on the bottom (and/or top) surface of thesubstrate unit 50 as the external terminals for connecting thetransformer assembly to other components of the IMD. As such, theterminal connectors 60 are exposed to facilitate the coupling of thetransformer assembly to other components of the IMD 20. For example, theprimary windings may be coupled to the battery (FIG. 2) and thesecondary windings may be coupled to the capacitors (FIG. 2).

FIG. 3B illustrates a cross-sectional view of an alternative transformerassembly 38 b. For ease of description, the elements of transformerassembly 38 b corresponding to those of transformer assembly 38 a arenumbered with identical reference designators. The reader is referred tothe preceding description of FIG. 3A for a full discussion pertaining tothose components.

In the embodiment of FIG. 3B, the transformer assembly 38 b includescircuitry 62 that is coupled to the substrate unit 50. In an embodiment,the circuitry 62 may be coupled on the substrate unit 50 adjacent to theupper magnetic core 56 and lower magnetic core 58. The specificcomponents included in circuitry 62 may vary and provide a variety offunctionalities. For example, some of the functionality of IMD 20 may beembodied in the components of circuitry 62. The components of circuitry62 are electrically coupled to one or more terminals 64. The terminals64 are connectable with additional components of IMD 20.

FIG. 4 depicts a cross-sectional view of another transformer assembly 38c. Transformer assembly 38 c includes a substrate unit 50. A portion ofthe substrate unit 50 is formed having embedded electronic components 52that may include a set of primary windings and secondary windings. Thesubstrate unit 50 further includes a pair of terminal connectors 60 thatare electrically coupled to the electronic components 52. Among otherthings, the terminal connectors facilitate coupling of the primary andsecondary windings to other components of the IMD 20. For example, theprimary windings may be coupled to the battery (FIG. 2) and thesecondary windings may be coupled to the capacitors (FIG. 2).

The substrate unit 50 is embedded within a unitary core 57. In oneembodiment, the unitary core 57 may be formed having a uniform thicknessaround opposing major surfaces 53 a, 53 b of the substrate unit 50. Aswill be described with reference to FIGS. 7A-B, core 57 encapsulatingthe substrate unit 50 is formed by a molding process that utilizes apolymer bonded magnetic compound. Briefly, the molding processfacilitates fabrication of custom dimensioned cores having package sizesthat are smaller relative to those achievable with conventional cores.The packages may be molded having excess (sacrificial) material thatfacilitates handling during the various processing tasks, with thematerial being removed during a grinding process to obtain desiredpackage dimensions.

FIGS. 5A to 5E depict cross-sectional views during tasks associated witha method for fabricating a transformer according to an embodiment of thedisclosure such as that shown in FIGS. 3A and 3B. A substrate (e.g., aprinted wiring board or a semiconductor wafer) having a plurality ofsubstrate units (e.g., 50 a, 50 b) is temporarily attached to a carrierplate. In the illustrative embodiment, the dotted line 100 demarcatesthe location where the substrate/wafer board having a plurality ofsubstrate units would be sawed to separate the individual transformerunits upon completion of the assembly. In one embodiment, the carrierplate is made of stainless steel and has a thickness of, for example,between 2 and 10 mm. The shape and size of the carrier plate maycorrespond to that of the substrate. The substrate is attached to thecarrier plate using an adhesive layer that has first and second opposingsurfaces, with a bottom surface of the substrate being mounted to thefirst opposing surface and a surface of the carrier plate being mountedto the second opposing surface. Although not specifically shown, theadhesive layer may comprise a thermal release tape that includesthermally-degradable adhesive. Another example of the adhesive layer maycomprise a solvent-soluble adhesive, in which case, the carrier plate ismade of a porous material that allows a solvent to pass therethrough,such as a composite material of aluminum oxide embedded in a glassmatrix.

In another embodiment, the substrate may be attached to a single-sidedPSA release tape that is not directly supported by a carrier plate. Inthe embodiment, the PSA release tape is suspended on a wafer mountingring, and the substrate is attached to the PSA release tape by vacuumlamination. Support for the PSA release tape and substrate is providedby a mold chase during molding.

The substrate may comprise a standard G-10 board that is used forprinted circuit boards, which include a copper conductor layer 51 etchedon the bottom surface of the substrate. Other suitable materials for thesubstrate include metals, ceramics, plastics, polymers, and combinationsthereof. The substrate is formed having electronic components 52 thatmay be disposed on a top surface, or partially embedded, or fullyembedded into the substrate material. In the simplest form, theelectronic components 52 may comprise a set of windings, including bothprimary and secondary windings. Each set of the primary and secondarywindings may be coupled to terminal connectors that are formed on thebottom (and/or top) surface of each substrate unit horizontally-adjacentto the windings.

As is shown in the cross-sectional view, the electronic components 52are arrayed to define depressions that extend vertically, in relation tothe top surface, into the body of the substrate. The exemplaryembodiment depicts the depressions being arrayed in the form of an “E”.Although the illustrative embodiment depicts the depressions beingformed through the entire length of the body, it is contemplated that inother embodiments the depressions may alternatively be formed onlypartially into the body of the substrate.

FIG. 5B illustrates an upper core that is placed over the top surface ofeach of the substrate units. In the illustrative embodiment, the uppercore is an “E” core and the legs are disposed within the depressionsformed on the substrate unit. As such, the upper core may be selectedhaving dimensions that enable the upper core to be placed over the topsurface of the substrate. The dimensions of the legs of the upper coreare also selected to fit within the depressions of the substrate unit.In other embodiments, the converse relationship may be defined in thedesign criteria—i.e., the substrate unit including the depressions maybe formed to match the dimensions of a pre-selected upper core. Theupper core may be a magnetic core formed from ferro-magnetic material,amorphous metal or other advanced materials as is known in the art.

Next, as illustrated in FIG. 5C, an encapsulant material is dispensed(e.g., formed, injected, or deposited) over the top surface of thesubstrate and the exposed portions of the upper core including the gapsbetween the upper core and the substrate. In one embodiment, theencapsulant material may be deposited having a consistentcross-sectional area around the substrate/core assembly. For example,the encapsulant material may be deposited to define a depth (orthickness) of, for example, approximately 1 mm around the substrate/coreassembly. In one embodiment, the encapsulant material is an electricallyinsulative material such as, a silica-filled epoxy, with a final curetemperature of, for example, between 140 and 150 degrees Centigrade(C.). Other embodiments may use other types of encapsulant materialsthat have higher filler content or that are low modulus compounds. Thecarrier plate, along with the various components supported thereon, issubsequently heated or “baked” in, for example, an oven. In oneembodiment, the baking is performed at a temperature of approximately100 degrees C. for 60 minutes.

Subsequent to, at least partial, curing (e.g., 40% cure), the exposedencapsulant material undergoes a grinding (and/or polishing, abrasion,milling) process to reduce the thickness of the molded assembly(encapsulant material and core) to a reduced, or thinned thickness as isshown in FIG. 5D. In other words, the molding process may includeforming during the molding process a package that is larger than thedesired final package to facilitate handling with the grinding processbeing performed to achieve the desired package dimensions. In thedepicted embodiment, the grinding process is performed using a polishingor grinding head (or polishing element) that is placed into contact withand pressed against the molded assembly while being rotated and movedacross the exposed surface of the assembly.

Turning next to FIG. 5E, the adhesive layer is separated from thesubstrate which in turn separates or unmounts the substrate from thecarrier plate. The separation may be performed by, for example, exposingthe adhesive to a solvent for a solvent-soluble adhesive, or heat, for athermally degradable adhesive. Removal of the adhesive layer exposes theterminals of the transformer assembly that are disposed on the bottomsurface of the substrate unit.

Additionally, a lower core is attached to the bottom surface of each ofthe substrate units. The lower core is placed in an overlapping relationto the upper core and away from the exposed terminals. The lower coremay be formed from materials similar to those of the upper coreincluding, but not limited to, magnetic materials. The lower core may beconfigured, for example, as an “I” core element and may be selectedhaving at least a length-wise dimension that is matched with the lengthof the upper core. Without intending to be limiting, the fixationbetween the lower core and the substrate unit may be achieved through apressure sensitive adhesive (PSA) compound. However, it should be notedthat any other type of adhesion technique and/or adhesive compound maybe utilized to achieve the bonding between the lower core and thesubstrate unit.

In embodiments in which the substrate includes more than one substrateunit, the substrate units are singulated along lines 100, for example,into individual units, such as those shown in FIGS. 3A and 3B.Singulation may be performed through, for example, sawing, or laseretching, or chemical singulation or any other methods known in the art.

Turning to FIGS. 6A-6C, tasks for assembly of a transformer inaccordance with an alternative embodiment are depicted. The tasks may beperformed prior to the singulation of the substrate into individualsubstrate units. In FIG. 6A, a plurality of conductive pads areconnected to the substrate, such that one pad is coupled to each of theterminal connectors. The conductive pads may be made of Aluminum (Al) orCopper (Cu) or any other conductive material with properties to enablesoldering. In some embodiments, one or more surface mountablecomponents, such as an integrated circuit (IC) (not shown), may also becoupled to the substrate unit's bottom surface having electricalterminals for connection of the IC to other components of the IMD.

Next in FIG. 6B, a carrier plate is attached to the top surface of themolded substrate. An adhesive layer may be used as described withreference to FIG. 5B to attach the carrier plate to the top surface. Anencapsulant material, such as that described above, is subsequentlydispensed over the bottom surface of the substrate assembly, whichincludes the adhered lower core. In embodiments having the surfacemountable component, the encapsulation of the bottom surface isperformed to also encapsulate such surface mountable components.Dispensing and curing of the encapsulant material may be performed inaccordance with the discussion above in conjunction with FIG. 5C.

Subsequently, after curing of the encapsulant material, the exposedencapsulant material on the bottom surface of the molded assemblyundergoes a grinding (and/or polishing, abrasion, milling) process toreduce the thickness of the molded assembly (encapsulant material andcore) to a reduced, or thinned thickness as is shown in FIG. 6C. Thegrinding also exposes the lower core and the conductive pads (and the ICterminals in embodiments having one or more ICs). In both grindingprocesses of FIGS. 6C and 5D, the lower and upper cores may also bethinned to a desired thickness, if appropriate. The top surface issubsequently separated from the carrier plate by detaching the adhesivelayer.

According to another embodiment of the present disclosure, anothermethod for assembling a transformer, such as that depicted in FIG. 4, isdisclosed which is illustrated in the FIG. 7A and FIG. 7Bcross-sectional views of exemplary processing tasks. In this method, ahomogeneous core is integrally formed around a substrate unit thatincludes a set of windings for the transformer. Unlike conventionaltransformer cores, the method of the embodiments described withreference to FIGS. 7A and 7B yield a homogenous transformer core thatcan be custom-made with any desired shape or size and tailored toindividual specifications and electrical performance characteristics.

Formation of the homogeneous core to encapsulate the substrate unit inaccordance with embodiments of the method enables customization of thethickness of the core's sections on opposing surfaces of the substrateunit. For example, the thickness around opposing surfaces may be formedto be uneven based on desired electrical performance characteristics ofthe transformer. In yet another example, the core may be formed bydistributing the encapsulant material uniformly around the substrateunit to define a consistent cross-sectional area for the magnetic path.

As shown in FIG. 7A, a mold chase 80 is provided for formation of thecore 57. The mold chase 80 includes an upper mold chase 82 having anupper cavity and a lower mold chase 84 having a lower cavity. Upper moldchase 82 and lower mold chase 84 may be formed with corresponding cavitydimensions such that a continuous or contiguous central cavity 86 isformed when the upper mold chase 82 is placed over the lower mold chase84. Additionally, each of the upper and lower cavities may be configuredin a shape and size corresponding to that of a desired upper and lowercore, respectively. Together, the upper and lower cavities define thecentral cavity 86 into which a substrate having one or more substrateunits 50 is received for encapsulation. Each substrate unit or substratehaving a plurality of adjoining substrate units 50 is placed over thetop surface of the lower mold chase 84, with the upper mold chase 82being separated from the lower mold chase 82. As discussed above, thesubstrate unit 50 is formed having one or more electronic components 52that include a set of primary and secondary windings.

In one example, the mold chase 80 includes a receptacle 88 that isformed, for example, at a central portion of the lower mold chase 84.The receptacle 88 includes a hollow interior that is in fluidcommunication with a first opening at an outer surface of the lower moldchase 84 and a second opening into the lower cavity. A plunger 90 isdisposed within the receptacle 88, and in use, the plunger 90 is movablewithin the receptacle in a direction toward the second opening totransfer an encapsulant material 54 held within the receptacle 88 intothe central cavity 86. As such, the plunger 90 may include a head plate92 that is dimensioned to fit circumferentially-around acylindrically-shaped receptacle, for example, with a pin 94 that isutilized for force transfer. The plunger 90 may be operated manually orunder a hydraulic pressure.

The encapsulant material 54 may be held in the receptacle in a molten orliquefied state to facilitate the transfer from the receptacle into thecentral cavity 86 and to ensure complete encapsulation of the substrateunits. Such encapsulation eliminates air gaps that may otherwise beformed between the substrate unit and the core.

The material selection for the encapsulant material is based on desiredelectrical functionality of the transformer and electrical properties ofthe core. Without intending to be limiting, the materials may includepolymer bonded magnetic compounds formed, for example, by mixing apolymer binder with magnetic powder. The polymer binder can be eitherthermoplastic or thermoset. Thermoplastic polymer binders include LiquidCrystal Polymer (LCP), polyamine (e.g., Nylon 6), andpolyphenylenesulfide (PPS) all of which are injection moldablematerials. Thermoset binders can either be transfer molded orcompression molded. Epoxy molding compounds are used in a transfermolding process while Phenolic and diallyl phthalate (DAP) resins can beused in a compression molding process. Soft magnetic powder can beMagnetics Molypermalloy Powder (MPP), soft ferrite, powdered iron,HI-FLUX, sendust, or Kool Mμ. Examples of polymer bonded magneticcompounds are commercially available from Arnold Magnetic TechnologiesCorporation of Rochester, N.Y.

Referring again to FIG. 7A, one or more outlet vents 96 are formed onthe mold chase 80 to facilitate dispensing of the encapsulant material.In the illustrative embodiment, the dispensing of the encapsulantmaterial 54 is performed in a transfer phase during which theencapsulant material 54 is expelled from the receptacle into the centralcavity 86. The outlet vents 96 prevent a build-up of pressure inside thecentral cavity 86 that would otherwise create an opposing force thatcounteracts the flow of the encapsulant material into the cavity 86.

Turning next to FIG. 7B, the encapsulant material 54 is illustratedhaving being dispensed into the central cavity 86 for encapsulation ofthe substrate. The dispensing of the encapsulant material 54 into thecavity is performed while ensuring complete coverage of each substrateunit. This can be done by rapidly filling the central cavity 86,generally prior to initiation of the curing of the encapsulant material.In other embodiments, the encapsulant material may be dispersed througha plurality of receptacles for even faster encapsulant filling. Afterthe encapsulant material is dispensed into the cavity, the moldedassembly is cured.

The specifics pertaining to the curing of the encapsulant material curewill depend on the properties of the selected material. For example, theencapsulant material may cure fairly rapidly without any processingtasks in one embodiment. In other words, allowing the molded assembly tosettle without more may permit the encapsulant material to betransformed into a solid state while it is held in the mold chase. Inother embodiments, further processing tasks may be performed to enhancecuring of the encapsulant material. For example, the mold chase may becooled to a temperature that causes the encapsulant material to betransformed into a solid state, or the material may be heated to atemperature that causes the encapsulant material to harden (e.g., above200° C.), or a chemical reaction may be performed, or the encapsulantmaterial may be irradiated, or any other processing that causes theencapsulant material to harden based on its properties.

Subsequent to the curing cycle the molded assembly is ejected from themold chase by separating the upper mold chase 82 from the lower moldchase 84. The molded assembly yielded includes one or more substrateunits encapsulated by an encapsulant material that becomes rigid todefine the core 57, as illustrated in FIG. 4. Similar to the embodimentsdescribed in the figures above, the molded assembly may be formed havingdimensions that are larger than the dimensions desired for a finalpackage to facilitate handling. The molded assembly may further undergoa grinding (and/or polishing, abrasion) process to reduce the thicknessof the core to a reduced, or thinned thickness. Further, in embodimentsin which the substrate includes more than one substrate unit, thesubstrate units may be singulated to yield individual substrate units asshown in FIG. 4.

It should be noted that the description of the tasks in FIGS. 7A and 7Bis merely exemplary of one molding process that can be used for forminga transformer assembly by encapsulating a substrate with an encapsulantmaterial to yield a continuous high permeability magnetic path. Thoseskilled in the art will recognize that the principles described in theabove tasks associated with a transfer molding process, may be embodiedin other molding processes such as compression molding or injectionmolding depending on the polymer bonded magnetic compound.

Moreover, the foregoing assembly methods describe construction of planartransformer assemblies formed with a substrate having one or more setsof primary windings and secondary windings. The techniques described inthe disclosure may, however, be suitably applied to assembly ofnon-planar transformers such as those having the primary and secondarywindings that are wound on a bobbin.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. In the above Detailed Description,various features may be grouped together to streamline the disclosure.This should not be interpreted as intending that an unclaimed disclosedfeature is essential to any claim. Rather, inventive subject matter maylie in less than all features of a particular disclosed embodiment.Thus, the following claims are hereby incorporated into the DetailedDescription, with each claim standing on its own as a separateembodiment. The scope of the invention should be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

1-17. (canceled)
 18. An implantable medical device having electroniccircuitry operable to perform a therapeutic and/or monitoring function,comprising: a battery; a capacitor; and a transformer coupled to thebattery and the capacitor, wherein the transformer includes: a substrateunit having electronic components and including primary and secondarywindings embedded within the substrate unit; a core encapsulating thesubstrate unit, wherein the core includes a unitary core having aunitary core that are molded to eliminate an air gap therebetween. 19.The implantable medical device of claim 18, wherein the configuration ofthe unitary core is selected based on a performance criteria for thetransformer.
 20. The implantable medical device of claim 18, wherein theunitary core comprises a polymer bonded magnetic compound.
 21. Atransformer assembly, comprising: a substrate unit comprising electroniccomponents embedded in a top surface of the substrate unit, wherein atleast one electronic component comprises primary and secondary windings;an upper magnetic core placed over the top surface of the substrate unitand the electronic components; a lower magnetic core placed over abottom surface of the substrate unit; and an encapsulant materialdispensed over exterior surfaces of the upper magnetic core and the topsurface of the substrate unit.
 22. The assembly of claim 21, furthercomprising encapsulant material disposed over exterior surfaces of thelower magnetic core.
 23. The assembly of claim 21, further comprising anadhesive material disposed between the lower magnetic core and thebottom surface of the substrate unit such that the lower magnetic coreis attached to the substrate unit.
 24. The assembly of claim 21, whereinthe encapsulant material dispensed over the exterior surfaces of theupper magnetic core and the top surface of the substrate unit is formedto expose an exterior surface of the upper magnetic core that isparallel to the top surface of the substrate unit.
 25. The assembly ofclaim 21, wherein the encapsulant material dispensed over the exteriorsurfaces of the upper magnetic core and the top surface of the substrateunit is also dispensed between one or more gaps formed between thesubstrate unit and the upper magnetic core.
 26. The assembly of claim21, further comprising a pair of terminal connectors coupled to theprimary and second windings of the at least one electronic component.27. The assembly of claim 26, wherein the pair of terminal connectors isformed at least partially on the bottom surface of the substrate unit.28. The assembly of claim 21, further comprising circuitry coupled tothe substrate unit.
 29. The assembly of claim 28, wherein the circuitryis disposed on the top surface of the substrate unit adjacent the uppermagnetic core.
 30. An implantable medical device comprising thetransformer assembly of claim
 21. 31. A method of forming a transformerassembly, comprising: providing a substrate comprising a substrate unit,wherein the substrate unit comprises electronic components disposed on atop surface of the substrate unit, wherein at least one electroniccomponent of the substrate unit comprises primary and secondarywindings; mounting the substrate to a first surface of an adhesivematerial; mounting a carrier plate to a second surface of the adhesivematerial; placing an upper magnetic core over the top surface of thesubstrate unit and the electronic components; dispensing encapsulantmaterial over exterior surfaces of the upper magnetic core and the topsurface of the substrate unit; curing the encapsulant material; grindingthe encapsulant material to reduce a thickness of the encapsulatedassembly; detaching the substrate from the adhesive material and thecarrier plate; and placing a lower magnetic core over a bottom surfaceof the substrate unit.
 32. The method of claim 31, wherein the primaryand secondary windings of the at least one electronic component of thesubstrate unit are coupled to terminal connectors that are formed on thebottom surface of the substrate.
 33. The method of claim 32, furthercomprising connecting a plurality of conductive pads to the substratesuch that a conductive pad of the plurality of conductive pads iscoupled to each terminal connector.
 34. The method of claim 31, whereingrinding the encapsulant material further comprises grinding the uppermagnetic core.
 35. The method of claim 31, wherein placing the lowermagnetic core on the bottom surface of the substrate unit comprisesattaching the lower magnetic core to the bottom surface of the substrateunit.
 36. The method of claim 31, further comprising: dispensing anencapsulant material over exterior surfaces of the lower magnetic coreand the bottom surface of the substrate unit; curing the encapsulantmaterial dispensed over the exterior surfaces of the lower magnetic coreand the bottom surface of the substrate unit; and grinding theencapsulant material dispensed over the exterior surfaces of the lowermagnetic core and the bottom surface of the substrate unit.
 37. Themethod of claim 36, wherein the substrate comprises a plurality ofsubstrate units, wherein the method further comprises singulating theplurality of substrate units into individual substrate units.